Study Status

Nickname Protocol Nickname
Study Status Active
Site Activation 176 / 190 (92.6%)
Participant Enrollment 1301 / 1300 (100.1%)

Study Overview

47 Red KRIs
71 Amber KRIs

Summary Charts

Group Overview

As of 2025-03-21, AA-AA-000-0000 has 1301 participants enrolled across 176 sites. 118 Site-KRI combinations have been flagged across 71 sites as shown in the Study Overview Table above.
  • 38 sites have at least one red KRI
  • 71 sites have at least one red or amber KRI
  • 105 sites have neither red nor amber KRIs

Results

Adverse Event Rate Simaerep

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X159 (Flores) 33 397 695 0.57 1.00
0X028 (Gonzales) 1 16 35 0.46 1.00
0X161 (Vangoey) 69 143 1442 0.10 -1.00
0X163 (el-Vaziri) 28 42 601 0.07 -1.00
0X124 (Salas Dominguez) 27 35 596 0.06 -1.00
0X080 (el-Mousa) 17 18 390 0.05 -1.00
0X153 (Voss) 28 25 597 0.04 -1.00
0X126 (Torres) 20 8 390 0.02 -1.00
0X003 (Drake) 13 4 276 0.01 -1.00
0X043 (Ford) 5 0 101 0.00 -1.00
0X024 (Rinard) 7 74 140 0.53 1.00
0X027 (Owens) 10 93 210 0.44 1.00
0X175 (Gonzalez) 16 129 366 0.35 1.00
0X180 (Tran) 12 12 261 0.05 -1.00
0X059 (Foster) 15 14 312 0.04 -1.00
0X106 (Hill) 5 1 107 0.01 -1.00
0X122 (el-Salameh) 17 23 352 0.07 -1.00
0X026 (el-Samra) 15 18 314 0.06 -1.00
0X125 (Pond) 10 11 230 0.05 -1.00
0X016 (el-Shaker) 7 7 161 0.04 -1.00
0X157 (Arellano) 9 6 188 0.03 -1.00
0X054 (Vargas Padilla) 2 33 47 0.70 1.00
0X041 (Yazzie) 3 37 66 0.56 1.00
0X164 (Jiron) 4 0 80 0.00 -0.99
0X090 (el-Attar) 1 17 16 1.06 0.99
0X160 (Liggett) 4 0 65 0.00 -0.99
0X169 (Kanack) 3 42 75 0.56 0.99
0X014 (Som) 25 150 533 0.28 0.99
0X188 (Jenkins) 7 58 158 0.37 0.99
0X178 (Kessenich) 11 12 221 0.05 -0.99
0X129 (Martinez) 10 18 240 0.07 -0.99
0X006 (al-Sultana) 4 34 82 0.41 0.98
0X063 (Pinto) 7 56 155 0.36 0.98
0X100 (Browne) 7 11 169 0.07 -0.98
0X035 (el-Saladin) 22 130 470 0.28 0.98
0X119 (Cousins) 5 4 107 0.04 -0.98
0X154 (Cloud) 23 138 544 0.25 0.97
X187X (al-Hasen) 8 9 165 0.05 -0.97
0X132 (Choi) 5 38 105 0.36 0.97
0X057 (Aragon) 6 43 130 0.33 0.97
0X116 (el-Ameen) 7 8 143 0.06 -0.97
0X013 (el-Allam) 6 8 136 0.06 -0.96
0X020 (Hamlin) 5 6 114 0.05 -0.96
0X179 (Terry) 3 24 65 0.37 0.96
0X173 (el-Yusuf) 1 2 3 0.67 0.96
0X069 (Ello) 4 4 96 0.04 -0.96
0X088 (Correa) 11 19 232 0.08 -0.96


Adverse Event Rate ZScore

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X159 (Flores) 33 400 697 0.57 6.62
0X027 (Owens) 10 114 210 0.54 3.35
0X024 (Rinard) 7 83 140 0.59 3.11
0X054 (Vargas Padilla) 2 35 47 0.74 2.45
0X090 (el-Attar) 1 17 16 1.06 2.22
0X175 (Gonzalez) 16 129 366 0.35 2.15
0X041 (Yazzie) 3 39 66 0.59 2.12
0X169 (Kanack) 3 42 75 0.56 2.10
0X153 (Voss) 28 25 597 0.04 -2.00
0X126 (Torres) 20 8 390 0.02 -1.88
0X124 (Salas Dominguez) 27 36 597 0.06 -1.72
0X161 (Vangoey) 69 148 1443 0.10 -1.67
0X003 (Drake) 13 5 276 0.02 -1.61
0X163 (el-Vaziri) 28 42 601 0.07 -1.58
0X080 (el-Mousa) 17 19 390 0.05 -1.53
0X026 (el-Samra) 15 18 314 0.06 -1.28
0X180 (Tran) 12 13 261 0.05 -1.24
0X122 (el-Salameh) 17 24 352 0.07 -1.23
0X157 (Arellano) 9 6 188 0.03 -1.21
0X125 (Pond) 10 11 230 0.05 -1.18
0X178 (Kessenich) 11 12 222 0.05 -1.11
0X043 (Ford) 5 0 102 0.00 -1.09
0X106 (Hill) 5 1 107 0.01 -1.06
0X016 (el-Shaker) 7 7 161 0.04 -1.03


Protocol Deviation Rate

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X155 (al-Sani) 4 49 81 0.60 1.00
0X030 (Hutchinson) 2 21 48 0.44 1.00
0X027 (Owens) 10 74 210 0.35 1.00
0X174 (Broughton) 3 21 64 0.33 1.00
0X142 (Garnett) 5 36 110 0.33 1.00
0X014 (Som) 25 0 533 0.00 -1.00
0X087 (Vigo) 27 0 620 0.00 -1.00
0X066 (Lipps) 1 13 23 0.57 1.00
0X123 (Martinez) 5 25 100 0.25 1.00
0X065 (Hill) 36 9 768 0.01 -1.00
0X033 (Taylor) 1 12 21 0.57 0.99
0X126 (Torres) 20 1 390 0.00 -0.99
0X026 (el-Samra) 15 40 314 0.13 0.99
0X104 (James) 12 33 263 0.13 0.99
0X082 (Ramirez) 8 26 170 0.15 0.99
0X045 (Horton) 4 18 92 0.20 0.99
0X039 (Kimler) 5 17 97 0.18 0.99
0X047 (Ruvalcaba) 1 10 20 0.50 0.98
0X041 (Yazzie) 3 14 66 0.21 0.98
0X143 (el-Salih) 8 27 192 0.14 0.98
0X081 (Hendee) 4 17 82 0.21 0.98
0X124 (Salas Dominguez) 27 55 596 0.09 0.98
0X156 (Ashcroft-Bitsilly) 9 26 201 0.13 0.98
X067X (Zamora) 1 9 20 0.45 0.98
0X131 (Tran) 1 7 16 0.44 0.98
0X077 (Gonzalez) 8 21 143 0.15 0.98
0X154 (Cloud) 23 48 544 0.09 0.98
0X012 (Mansfield) 5 19 103 0.18 0.98
0X091 (Ostrom) 20 2 448 0.00 -0.97
0X127 (Pascual) 4 15 89 0.17 0.96
0X167 (al-Koroma) 43 18 920 0.02 -0.96
0X063 (Pinto) 7 19 155 0.12 0.95


Protocol Deviation Rate ZScore

Summary Charts

Scatter Plot
Bar Chart
Metric Table
Group Enrolled Numerator Denominator Metric Score Flag
0X155 (al-Sani) 4 49 81 0.60 5.43
0X027 (Owens) 10 74 210 0.35 4.76
0X142 (Garnett) 5 36 110 0.33 3.15
0X030 (Hutchinson) 2 21 48 0.44 2.92
0X066 (Lipps) 1 13 23 0.57 2.69
0X033 (Taylor) 1 12 21 0.57 2.60
0X174 (Broughton) 3 21 64 0.33 2.41
0X047 (Ruvalcaba) 1 10 20 0.50 2.19
0X123 (Martinez) 5 25 100 0.25 2.16
0X087 (Vigo) 27 0 620 0.00 -1.41
0X014 (Som) 25 0 533 0.00 -1.30
0X065 (Hill) 36 9 768 0.01 -1.21
0X091 (Ostrom) 20 2 448 0.00 -1.09
0X167 (al-Koroma) 43 18 922 0.02 -1.07
0X126 (Torres) 20 1 390 0.00 -1.06


Metric Details

Type ID GroupLevel Abbreviation Metric Numerator Denominator Model Score AnalysisType Threshold nMinDenominator Priority MetricID
Analysis kri0001 Site AE-Simaerep Adverse Event Rate Simaerep Adverse Events Visit bootstrap-simaerep Over/Under-Reporting Probability identity -0.99, -0.95, 0.95, 0.99 1 0 Analysis_kri0001
Analysis kri0002 Site AE-ZScore Adverse Event Rate ZScore Adverse Events Visit Normal Approximation Adjusted Z-Score rate -2,-1,2,3 1 0 Analysis_kri0002
Analysis kri0003 Site PD-Simaerep Protocol Deviation Rate Protocol Deviation Simaerep Visit bootstrap-simaerep Over/Under-Reporting Probability identity -0.99, -0.95, 0.95, 0.99 1 0 Analysis_kri0003
Analysis kri0004 Site PD-ZScore Protocol Deviation Rate ZScore Protocol Deviation Visit Normal Approximation Adjusted Z-Score rate -2,-1,2,3 1 0 Analysis_kri0004